ASTM F1266-89(1998)

Standard Performance Specification for Cerebral Stereotactic Instruments

SCOPE
1.1 This specification covers stereotactic instruments used by neurosurgeons to assist in the placement of probes, such as cannulae, needles, forceps, or electrodes or to direct radiation into brain regions or anatomical targets that are not visible on the surface. The general location of these regions is determined by measurements from landmarks visualized by X ray or other means, such measurements being based on atlases derived from anatomical studies and autopsy. Because of the anatomical variability, more precise location in any single patient may be determined by physiological responses in that patient. The degree of success in stereotactic surgery depends upon the experience of the surgeon as well as the precision of the stereotactic instrument. Nevertheless, minimum standards of accuracy for stereotactic instruments that are within the range of variability of human anatomy must be maintained.
1.2 For the purpose of this specification, a stereotactic instrument is a guiding device used in human neurosurgery for the purpose of directing an instrument or treating modality to a specific point within the brain by radiographic or other visualization of landmarks.
1.3 Stereotactic instruments must be constructed to afford the surgeon reliably reproducible accuracy in placing instruments into target areas. Proper positioning of the probe is often verified by X rays to control errors in calculation and to correct deflection of the probe during insertion. Physiological parameters may be used to further define the optimal target.
1.4 At the present time, stereotactic instruments are used most frequently, but not exclusively in the following operations. The list is presented only to present examples and should not be construed to restrict advances or developments of new procedures. For some applications it is not required to hit a point in space, but to hit a volume or make a lesion within a mass. For that purpose, devices other than those covered by this specification may be employed, but should be restricted to such uses.
1.4.1 Thalamotomy for parkinsonism and other types of tremor,
1.4.2 Electrode implantation for epilepsy,
1.4.3 Needle or magnetic insertion, or both, for aneurysm thrombosis,
1.4.4 Thalamic or subthalamic operations for dystonia,
1.4.5 Thalamic or subthalamic operations for involuntary movements such as chorea or hemiballismus,
1.4.6 Ablation of deep cerebellar nuclei for spasticity,
1.4.7 Cingulotomy and thalamic or subthalamic surgery for pain,
1.4.8 Mesencephalotomy or tractotomy for pain,
1.4.9 Ablations of subcortical temporal lobe structures for treatment of epilepsy,
1.4.10 Psychosurgical procedures,
1.4.11 Implantation of depth stimulating electrodes for pain,
1.4.12 Insertion of forceps or needle for obtaining biopsy specimens,
1.4.13 Foreign body removal,
1.4.14 Implantation of radioactive material, and
1.4.15 Biopsy or treatment of tumors.
1.5 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Dec-1997
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.31 - Neurosurgical Standards

Relations

• Replaced By: ASTM F1266-89(2002) - Standard Performance Specification for Cerebral Stereotactic Instruments
• Effective Date: 27-Nov-1989

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or
withdrawn. Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1266 – 89 (Reapproved 1998)
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Performance Specification for
1
Cerebral Stereotactic Instruments
This standard is issued under the fixed designation F 1266; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 1.4.4 Thalamic or subthalamic operations for dystonia,
1.4.5 Thalamic or subthalamic operations for involuntary
1.1 This specification covers stereotactic instruments used
movements such as chorea or hemiballismus,
by neurosurgeons to assist in the placement of probes, such as
1.4.6 Ablation of deep cerebellar nuclei for spasticity,
cannulae, needles, forceps, or electrodes or to direct radiation
1.4.7 Cingulotomy and thalamic or subthalamic surgery for
into brain regions or anatomical targets that are not visible on
pain,
the surface. The general location of these regions is determined
1.4.8 Mesencephalotomy or tractotomy for pain,
by measurements from landmarks visualized by X ray or other
1.4.9 Ablations of subcortical temporal lobe structures for
means, such measurements being based on atlases derived
treatment of epilepsy,
from anatomical studies and autopsy. Because of the anatomi-
1.4.10 Psychosurgical procedures,
cal variability, more precise location in any single patient may
1.4.11 Implantation of depth stimulating electrodes for pain,
be determined by physiological responses in that patient. The
1.4.12 Insertion of forceps or needle for obtaining biopsy
degree of success in stereotactic surgery depends upon the
specimens,
experience of the surgeon as well as the precision of the
1.4.13 Foreign body removal,
stereotactic instrument. Nevertheless, minimum standards of
1.4.14 Implantation of radioactive material, and
accuracy for stereotactic instruments that are within the range
1.4.15 Biopsy or treatment of tumors.
of variability of human anatomy must be maintained.
1.5 This standard does not purport to address all of the
1.2 For the purpose of this specification, a stereotactic
safety concerns, if any, associated with its use. It is the
instrument is a guiding device used in human neurosurgery for
responsibility of the user of this standard to establish appro-
the purpose of directing an instrument or treating modality to
priate safety and health practices and determine the applica-
a specific point within the brain by radiographic or other
bility of regulatory limitations prior to use.
visualization of landmarks.
1.3 Stereotactic instruments must be constructed to afford
2. Referenced Documents
the surgeon reliably reproducible accuracy in placing instru-
2.1 NFPA Standard:
ments into target areas. Proper positioning of the probe is often
2
NFPA 99 Health Care Facilities Code (56A and 76B-T)
verified by X rays to control errors in calculation and to correct
2.2 UL Standard:
deflection of the probe during insertion. Physiological param-
3
UL 544 Electrical, Medical, and Dental Equipment
eters may be used to further define the optimal target.
1.4 At the present time, stereotactic instruments are used
3. Terminology
most frequently, but not exclusively in the following opera-
3.1 Descriptions of Terms—The following descriptions of
tions. The list is presented only to present examples and should
terms are for the purposes of this specification only. Other
not be construed to restrict advances or developments of new
nomenclature may be used throughout the literature and by
procedures. For some applications it is not required to hit a
various manufacturers:
point in space, but to hit a volume or make a lesion within a
3.1.1 anatomical accuracy—the reliability or accuracy with
mass. For that purpose, devices other than those covered by
which the tip of a probe can be introduced into a given
this specification may be employed, but should be restricted to
anatomical target. Because of anatomical variability, a given
such uses.
anatomical structure or anatomical target may vary relative to
1.4.1 Thalamotomy for parkinsonism and other types of
the position of the reference atlas position of that structure.
tremor,
Consequently, it is not possible to relate the reliability of a
1.4.2 Electrode implantation for epilepsy,
stereotactic apparatus to anatomical accuracy, but only to
1.4.3 Needle or magnetic insertion, or both, for aneurysm
mechanical accuracy.
thrombosis,
1 2
This specification is under the jurisdiction of ASTM Committee F-4 on Medical Available from National Fire Protection Association, Batterymarch Park,
and
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